IoT is making its move into healthcare. MEDTECH is going through an evolution and increasing usability, moreover the consumer market is also demanding more home-use health applications. COVID-19 requires social distancing is an example for this demand. The last 12 month show how cloud-based IoT solutions in healthcare do have several advantages. This is the main reason for this steep growth.
As well as traditional healthcare, Consumer Electronics manufacturers, but also pharmaceutics do see the opportunities and possibilities in this evolution of the healthcare industry. From traditional applications and devices, now healthcare solutions are integrated in consumer electronics as wearables etc.. However, multi-compliance regulations applicable to these devices. Placing your MEDTECH on the market in this industry is not without challenges. Complying to one directive or regulation can be a challenge for a manufacturer. The mix of 2 and even more will be an even bigger challenge.
Due to COVID-19 the MDR (Medical Devices Regulations 2017/745/EU) will get into force as from May 26th. 2021. 2021 will become an exciting year considering this enforcement.
The Internet of Things in healthcare and IOMT and cybersecurity
The intersection of the Internet of Things (IoT) and Healthcare has become so prominent that it has earned its own synonymous: Internet of Medical Things (IOMT). The internet of Medical things connects health systems, applications, services and devices over the cloud with the use of wireless transmission (Bluetooth, 5G, NBIoT etc..). It revolutions the ways patients are approached and healthcare data is managed. Ultimately the IoT in healthcare improves the medical services and overall quality of healthcare.
A big concern is patient privacy and the protection of personal information, which can be a challenge for the development of these IoMT devices. Yes, technology does improve healthcare in a lot of ways, but how far is too far?
IoT devices also have their own challenges when it comes to keeping connections secure and stable. Any IoMT security vulnerabilities leave medical devices open to hacking and malware which can cripple medical care if not addressed. Increased vigilance, network segmentation, security patching and keeping software up to date are a few ways that the healthcare industry can help to safeguard their tools and patient data.
As the IoT in healthcare comes with its challenges, by complying to country regulations challenges can be mitigated.
Medical Devices need to comply with a variety of Medical compliance regulations. Every country/region applies to its own version. FDA in the USA, Health Canada in Canada, in the EEA the MDR (2017/745) as from May 26th. etc. etc.. Whereby Wireless devices also need to comply with several radio regulations depending on the market coverage. Examples are FCC for the US, ICES for Canada or for Europe the Radio Equipment Directive (2014/53/EU). Which regulation to comply to is depending on your global coverage. You can find a regularly updated global overview here.
IoT Consulting Partners.
Healthcare and Internet of Things devices are regulated industries with very few globally harmonized requirements. Building and executing a regulatory plan that accounts for both IoT and Healthcare compliance, as early as possible in the product design, will ensure requirements are met, ease market clearances and guarantee cost efficiency.
For more information how IoT Consulting Partners can assist you in your Internet of Medical Things solutions, feel free to contact us.